Events

HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2014-RN-00200-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00200-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Integra neurosciences has recently identified, through an internal evaluation, a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection. the risk for an adverse patient consequence has been determined to be not likely based on the manufacturer’s health hazard evaluation.
  • 조치
    Integra trained representatives will be performing an inspection of the affected components at the healthcare facility before each surgery by following a verified inspection process. This will assure that only products without damages external pouches are used in surgeries.

Device

HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)Multiple Catalogue Numbers affected All unexpired lotsARTG Number: 173960
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd